Translatability of the S7A core battery respiratory safety pharmacology studies: Preclinical respiratory and related clinical adverse events.

Paglialunga, Sabina; Morimoto, Bruce H; Clark, Matthew; Friedrichs, Gregory S

Paglialunga, Sabina; Morimoto, Bruce H; Clark, Matthew; Friedrichs, Gregory S.

Paglialunga S; Celerion, Tempe, AZ, United States of America.
Morimoto BH; Alkahest, Inc., San Carlos, CA, United States of America.
Clark M; Elsevier, Philadelphia, PA, United States of America.
Friedrichs GS; Novartis Institue of Biomedical Research, East Hanover, NJ, United States of America. Electronic address: greg.friedrichs@novartis.com.

J Pharmacol Toxicol Methods ; 99: 106596, 2019.

Article en En | MEDLINE | ID: mdl-31173885

Palabras clave

Adverse drug reactions; Concordance; ICH S7A; Likelihood ratio; Methods; Nonclinical predictive value; Pulmonary

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Texto completo: 1 Banco de datos: MEDLINE Tipo de estudio: Guideline / Prognostic_studies / Qualitative_research Idioma: En Año: 2019 Tipo del documento: Article

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Texto completo: 1 Banco de datos: MEDLINE Tipo de estudio: Guideline / Prognostic_studies / Qualitative_research Idioma: En Año: 2019 Tipo del documento: Article